Category Archives: Drug Quality

Meike Schleiff of the Department of International Health, The JHU Bloomberg School of Public Health has explored how Burkina Faso manages to get essential medicines, including those for malaria, to the front line health services. She explains that the World Health Organization (WHO) has determined essential medicines to be, “those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.”(WHO, 2018) These medicines should be available as part of health systems functioning to all persons at appropriate amounts, affordable costs, quality standards and sufficient information assured to consumers. Every country develops an essential drug list,

Essential Medicines in
Burkina Faso are purchased and distributed primarily through the Centrale
d’Achats des Médicaments Essentiels (CAMEG), or Central Purchasing of Essential
Drugs system.(CAMEG, 2018)
This CAMEG system operates with two agencies in Ouagadougou, and then has seven
additional agencies in other zones of the country (see map). From the zonal
agencies, the CAMEG supplies 67 District Dispatching Depots (DRDs), and also
supplies University Hospital Centers, regional hospitals, and additional
services provided by the Ministry of Health. For the private sector, the CAMEG
manages supplies for NGOs, faith-based organizations, medical laboratories,
pharmaceutical companies, and the Global Fund for HIV, tuberculosis, and
malaria.(CAMEG, 2018)

Before the CAMEG was created, access to essential medicines
and supplies was very difficult, particularly for rural and other hard to reach
populations. This was due to geographical access as well as high prices for
specialty drugs, limited availability of generic drugs, and prohibitive
regulations against the introduction of generic medicines. In response to this
situation, the CAMEG was created under a presidential decree in 1992 and
commenced activities in 1994. In 1997, an evaluation was carried out to determine
the impact of the CAMEG and decide whether to continue the activities through a
long-term structure; the results of this evaluation proposed establishing a
legally and financially autonomous non-profit entity to carry forward the work
of the CAMEG.(CAMEG, 2018)
Today, the CAMEG manages the selection of drug suppliers for the country,
ensures compliance with WHO and national regulations on price and quality, and
facilitates distribution and storage of drugs across the country. A full
product list of the drugs managed by the CAMEG can be found on their website (www.cameg.com).

Medicines Reach Front-Line Health Facility

Community Level

The
availability of essential generic medicines at health and social welfare
centres in Burkina Faso is 74.5%, compared with an average of 40% across the
African region and less than 60% globally.(World
Health, 2016, Ministry of Health, 2010) For hospitals, rates are slightly
lower with 61% of generics available and regional hospital centers and 39% at
university hospital centers (Saouadogo
and Compaore, 2010), but only 1.2% of branded medicines;
this situation results in patients who are referred to hospitals from lower
level facilities often being forced to purchase medicines from more expensive
private pharmacies in order to receive the necessary care at higher levels of
the health system.(Vervoort,
2012)

While immense
progress has been made in ensuring affordability and accessibility of essential
medicines in Burkina Faso, mark-ups at different points along the supply chain
still result in prohibitively high prices at final points of sale; patients
still pay for 37% of the cost of essential medicines and remain the single greatest
healthcare cost for households in Burkina and a burden for the majority of the
population who still live on less than $1.25 per day.(Vervoort,
2012)

“On February 2, 2010, NAFDAC launched the NAFDAC MAS, putting the power of product verification right in the hands of the consumer. MAS is powered by Sproxil’s award-winning cloud-based Mobile Product Authentication™ technology, and remains the world’s largest nation-wide implementation of consumer-facing SMS anti-counterfeiting technology in the world.”

Below are two malaria medicine packets recently purchased. After scratching the small label (see it circled, we got the SMS messages as posted. The NAFDAC registration number alone is not enough to ascertain the validity. This is a smart procedure, even without a smart phone. Of course one still needs to read the expiry dates!

The recently concluded Global Health Systems Research Symposium in Cape Town featured a number of abstracts that touched directly or indirectly on malaria. Malaria services and movement toward malaria elimination cannot be achieved in a country without a strong health system that involves both communities, program staff and policy makers.

Below is an abstract by Freddy Kitutu, Chrispus Mayora, Phyllis Awor, Forsberg Birger, Stefan Peterson, and Henry Wamani of Makerere University and the Karolinska Institute on use of medicine shops in Uganda.

“Under-five child mortality in Uganda is still high and majority is caused by easily treatable pneumonia, malaria and diarrhoeal diseases among the poorest people. One of the reasons for these deaths is the lack of timely access to proven life saving medicines. This hinders progress towards attainment of MDG 4 target by 2015.

“To increase access to quality medicines and diagnostics for child febrile illnesses, Makerere University School of Public Health (MakSPH) in collaboration with WHO Alliance for Health Policy and Systems Research, is doing a project to assess the potential to deliver quality integrated care for malaria, pneumonia and diarrhoea using integrated community case management (iCCM) strategies and tools. Hence, an assessment was conducted to determine baseline care seeking preferences.

“A baseline household survey interviewed caregivers of children under-five years. The study protocol and data collection tools had been reviewed and approved by Research and Ethics Committees at WHO, MakSPH and Uganda National Council of Science and Technology.

“A total of 2606 households were surveyed. The main childhood diseases reported included fever (70%), cough (77%), and diarrhoea (40%) convulsions (16%) Most households use private drug shops to purchase medicines to manage these illnesses. Use of drug shops was attributed to long distances to public health facilities, availability and reliability of drug stocks at drug shops, perceived high quality of services, and options for credit.

“Interventions that target public health facilities are likely to miss many healthcare seekers especially the poor in rural distant areas. Conclusion: Drug shops are the convenient and preferred outlets for rural poor communities, and therefore need to be included in interventions such as iCCM strategy.

“Significance for the selected field-building dimension: This abstract presents findings from the baseline assessment prior to introducing a health system intervention in drug shops to improve access to and quality of care for under-five children.”

Patent medicine vendors (PMVs) , also known as medicine shop owners, are a major source of malaria medicines. This qualitative examination of how PMVs perceive their business was conducted by Kabiru Salami, Bill Brieger and Stephen Kodish.

Access to high-quality, affordable medicines is a global concern but manifests in distinctly local ways. In Nigeria, patent medicine vendors (PMVs) are a major source of medicines. Criticism of PMVs focuses on drug quality, dispensing practices, and their lack of formal health care training.

This qualitative investigation approached PMVs as small business people and sought their business perspectives in comparison with views of other small business owners in Igbo-Ora, Nigeria. This study utilized an iterative approach to data collection among 51 entrepreneurs.

Accounts from participants reveal differences between PMVs and other businesses including amount of education necessary to learn the trade, as well as the level of professionalism and cleanliness required to operate successfully. Unlike other groups, PMVs routinely are asked for highly technical information at point of purchase.

PMVs work largely under strong trade associations due to more controls imposed by regulatory agencies. Although selling medicine is a small-scale enterprise, the purveyors of the trade see their work differently from other small business people. Their business model is based on having adequate knowledge about their products and maintaining standards. PMVs can increase human resources for health because they want to improve both their work and business prospects.

The use of sulphadoxine-pyrimethamine (SP) intermittent preventive treatment of malaria in pregnancy (IPTp) has been offered in stable malaria transmission countries for over a decade.Â As observations continued that SP resistance was growing in children treated for malaria, SP was dropped as a recommended treatment drug in all malaria-endemic countries in Africa.Â Ironically SP is still commonly found in pharmacy and medicine shops in many countries.

While SP resistance in child treatment has been documented, studies directly testing this in pregnant women have not been designed due to the usual concerns aboutÂ the effect of medicines in pregnancy. Already the recommendation for IPTp excluded its use in the first trimester. What has been observed though not that SP does not work, but that its half-life or period of effectiveness has been reduced. Therefore WHO still recommends SP for IPTp, but more frequently.

In order to prevent SP efficacy as used in IPTp from eroding further, there have been strong calls for stopping its use for treatment. This has proved challenging since SP may cost less that one US dollar per dose, while ACTs, if not available free in government clinics (if no stock-outs), cost up to $6-$8 for adult doses. No wonder there is an economic appear to continue to stock SP in private shops for sale as an antimalarial. Even in public clinics SP meant for IPTp may be used by staff when there are ACT stock-outs.

It would seem that most of our national health authorities believe more in the economic laws of supply and demand than in the technical guidelines of WHO. Otherwise SP would not be so widely available in shops. Whether private sector sales of SP are ignored by health authorities or actually tolerated by them, the result is still a threat to mothers and unborn children whose lives can be saved by maintaining the efficacy of SP and banning sales and inappropriate use of SP.Â Courage to stand up to private sales is needed.

On a closing note, you will have noticed the picture of the SP packet attached here. It is produced by a Kenyan company and was found in a pharmacy in Malawi. The manufacturer is clearly hoping to rebrand its product. The pharmacist admitted though that few have been sold since pregnant women get SP free at ANC.

Fortunately the shop is not promoting this SP for treatment but instead sells a brand of artemether-lumefantrine. Even this newly repackaged SP product for home use is inappropriate as IPTp should be given as directly observed treatment by a health worker. We should not let such inappropriate use of SP be hidden behind clever packaging. National Malaria Programs and Drug Authorities must join hands to restrict SP use for IPTp.

The Affordable Medicines Facility malaria (AMFm) was aimed at ensuring high quality low cost medicines reached the public and saved lives.Â Nigeria was one of the biggest challenges for AMFm with having the highest burden of disease of any single country.Â Unfortunately the vastness of the problem seemed to work against the effort.

Instead of concentrating the resources on a few pilot states of local government areas, as often happens, the project was spread thinly across the nation. There was no way that enough medicine would be provided to treat the large number of cases seen annually in the country. In the states only selected medicine shops received training and supplies. Out-of-stock syndrome was common.

One can find the AMFm logo on empty boxes of medicine as seen in the attached photos from medicine shops.Â The shop keepers do find the boxes useful for storing other things, and then resort to selling chloroquine to their customers. When will we learn how to conduct pilot programs so that thy actually produce meaningful results and guide future policy decisions?

Paul Kartchner contributes this guest blog via the SBFPHC Policy Advocacy Blog.For years, a major obstacle to controlling malaria in developing countries has been the high cost of effective medications. Yet in recent years a coalition of public health agencies and organizations are targeting this problem by subsidizing the most effective medications. Called the Affordable Medicines Facility â€“ malaria (AMFm), the project hopes to make these medications more available and affordable to hospitals, physicians, and local pharmacies in developing countries.

Yet even though the project hasÂ been found to increase the supply of medications, criticisms have been raised regarding the programâ€™s long-term benefits.Â A recent reportÂ by Oxfam, an international aid group, claims that although these medications are now broadly available, they are not being used appropriately to treat patients with malaria. They also claim that many patients that do need these medications, including women and children, still do not have access to them.

These criticisms raise important questions about the nature of complex global diseases such as malaria. Focusing efforts and resources on a particular aspect of a problem without considering the larger context may not only fail to improve the situation, but potentially make it worse.

Tuberculosis is one of the big three receiving Global Fund support, and like HIV and malaria control efforts, the emphasis is on multiple interventions to ensure ultimate success. Compared to the other diseases, TB’s interventions have been mainly limited to immunization and directly observed treatment. Both of these interventions have recently met some major challenges that have also plagued the other big diseases.

Roger Bate and colleagues, who have focused on the problems of fake and substandard malaria drugs have turned their attention to TB. (see http://masetto.ingentaselect.co.uk/fstemp/a5829970064042ab6ec12023d514ef4f.pdf ). Their investigation at pharmacies in 19 Asian and African countries found around 9% of TB drugs were substandard/poor quality. The rate of fake medicines was 16% in Africa and 10% in Asia.

Governments in these countries were encouraged to give these issues greater attention including better regulation and collaboration with international policing efforts.

The need for new vaccines is a necessary development to maintain a strong disease control arsenal. For TB, “A new vaccine, modified Vaccinia Ankara virus expressing antigen 85A (MVA85A), was designed to enhance the protective efficacy of BCG.” (as reported in The Lancet http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2960177-4/abstract )

As the BBC report on this study pointed out, “BCG is only partially effective against the bacterium that causes TB, which is why several international teams are working on new vaccines.” (see BBC at http://www.bbc.co.uk/news/health-21302518 )

While the new vaccine “… was well tolerated and induced modest cell-mediated immune responses. Reasons for the absence of MVA85A efficacy against tuberculosis or M tuberculosis infection in infants need exploration.” Fortunately research on other vaccine candidates is underway.

Continued control and eventual elimination of malaria and TB will require research that is both basic (vaccines) and applied (drug quality) in order to develop, maintain and implement effective strategies. Disease research budgets should not be compromised in the ever changing world of pathogen/parasite evolution.

While some countries are being praised this week for their progress in controlling malaria, Uganda seems to be suffering from a double knock out punch when it comes to malaria financing. Challenges have appeared in both the private and public sectors.

The private sector challenge has come in the form of fake medicines in local shops. This comes in the form of a threat to individuals and families who spend their hard earned cash, that is out-of-pocket expenditure (OOP) of malaria medicines that at best inappropriate and at worse are devoid of active ingredients, increasing the likelihood that the sick person will develop severe disease and maybe die.

Specifically the Washington Post reported that an indigenous medical practitioner â€œin Kampala, says he has seen a big increase in business as patients turned off by the prospect of dangerous fake drugs seek relief from illness.â€ The article explains that although â€œOfficials and international aid agencies have long encouraged the sick to place their trust in modern medicine. But fake pharmaceuticals believed to have come from Asia have floodedâ€ African Markets including Uganda.

The irony is that Uganda is part of the testing of the Affordable Medicines Facility malaria (AMFm) project that was supposed to drive out fake and inappropriate medicines by making low cost (subsidized) quality antimalarials available in both public and private sectors. While Uganda witnessed an increase in market share of the green-leaf branded quality assured artemisinin-based combination therapy drugs, it did not achieve other benchmarks such as supportive behavior change communication and low cost targets (mark-up averaged 133% – highest among the 8 pilots).

The second threat comes from extensive embezzlement by national malaria program staff.Â Earlier this month Uganda was in the news for returning 4 million Euro of misappropriated funds to the Irish Government.

“An investigation into the financial practices of officials running the ministry of Health’s Malaria Control programme (MCP) shows they forged almost everything from workshops, car hires, allowances and fuel expenses. The investigation has now shifted its focus to the extent of the forgery and theft by officials implicated in the loss of nearly Shs 78bn (US $29m). The shift in the focus of the inquiry follows a review of stacks of documents provided by three suspects involved in the MCP scandal. Police confirm that the documents show the extent of the forgery by some officials involved in the anti-malaria campaign.”

In these times when it is difficult to increase health development spending for malaria both domestically and from international donors, all efforts are needed to ensure that waste and fraud are eliminated.

https://t.co/yKKsmAEpSv @MinSanteRDC #Ebola 23 May 2019: Since beginning of epidemic, cumulative number of cases is 1,888, of which 1,800 confirmed 88 are probable. In total, there were 1,254 deaths (1,166 confirmed and 88 probable) and 492 people cured. 11 new confirmed cases